EzRay Air Portable (Model: VEX-P300)

FDA 510(k)

FDA Class 2 ·Dental

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SM-EXTRA WIDE (RBM) IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

EzRay Air W

FDA 510(k)

FDA Class 2 ·Dental

OPTOVISION Endoscopic Light Source Unit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOMATOM DEFINITION FLASH

FDA 510(k)

FDA Class 2 ·Radiology

SPEEDY FLAP SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

IMC SURGICAL DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CastleLoc Pectus Bar System

FDA 510(k)

FDA Class 2 ·Orthopedic

PROcedure Rehearsal Studio

FDA 510(k)

FDA Class 2 ·Radiology

LORENZ ORTHODONTIC ANCHORAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

1717FCC

FDA 510(k)

FDA Class 2 ·Radiology

HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC

FDA 510(k)

FDA Class 2 ·Radiology

TruAbutment DS

FDA 510(k)

FDA Class 2 ·Dental

ARIX Humerus System

FDA 510(k)

FDA Class 2 ·Orthopedic

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

FDA 510(k)

FDA Class 2 ·Dental

SUPER NOVA, ACUBEAM

FDA 510(k)

FDA Class 2 ·Physical Medicine

GUA60A, GU60A-65

FDA 510(k)

FDA Class 2 ·Radiology